NCT04742764暂停3 期
Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS): a Prospective, Randomized, Multicenter Clinical Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Time to shock reversal
研究概览
简要总结
Sepsis and septic shock have mortality rates between 20-50%. When standard therapeutic measures fail to improve patients' condition, additional therapeutic alternatives are applied to reduce morbidity and mortality. One of the most recent alternatives is extracorporeal cytokine hemoadsorption. One of the most tested devices is CytoSorb, however, there are a lot of open questions, such timing, dosing and of course its overall efficacy. This study aims to compare the efficacy of standard medical therapy (Group A, SMT) and continuous extracorporeal cytokine removal with CytoSorb therapy in patients with early refractory septic shock. Furthermore, we compare the dosing of CytoSorb adsorber device - as the cartridge will be changed in every (12 Group B) or 24 hours (Group C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
No masking is applied in this study, as it is impossible to blind the medical personnel and participants. Statisticians will be blinded to allocation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic shock as defined by the Sepsis-3 criteria
- •Septic shock both medical or surgical ethiology (except for re-operation)
- •APACHE > 25
- •Mechanical ventilation
- •Norepinephrine requirement ≥0.4 µg/kg/min for at least 30 minutes, when hypovolemia is highly unlikely as indicated by invasive hemodynamic measurements assessed by the attending physician
- •Invasive hemodynamic monitoring to determine cardiac output and derived variables
- •Procalcitonin level ≥ 10 ng/ml
- •Inclusion within 6 - 24 hours after the onset of vasopressor need and after all standard therapeutic measures have been implemented without clinical improvement (i.e.: the shock is considered refractory)
排除标准
- •Patients under 18 years and over 80
- •Lack of health insurance
- •Pregnancy
- •Standard guideline-based medical treatment not exhausted (detailed below at 3.6) standard medical therapy)
- •End stage organ failure
- •New York Heart Association Class IV.
- •Chronic renal failure with eGFR < 15 ml/min/1,73 m2
- •End-stage liver disease (MELD score >30, Child-Pugh score Class C
- •Unlikely survival for 24 hours according to the attending physician
- •Acute onset of hemato-oncological illness
- •Post cardiopulmonary resuscitation care
- •Re-operation in context with the septic insult
- •Immunosuppression
- •systemic steroid therapy (>10 mg prednisolon/day)
- •immunosuppressive agents (i.e.: methotrexate, azathioprine, cyclosporin, tacrolimus, cyclophosphamide)
- •Human immunodeficiency virus infection (active AIDS): HIV-VL > 50 copies/mL
- •Patients with transplanted vital organs
- •Thrombocytopenia (<20.000/ml)
- •More than 10%-of body surface area with a third-degree burn
- •Acute coronary syndrome
结局指标
主要结局
Time to shock reversal
时间窗: From the start of the treatment until shock reversal assessed up to 5 days
The time from the start of the treatment (T0) until shock reversal
Shock reversal
时间窗: At the time of shock reversal assessed up to 5 days
Proportion of patients achieving shock reversal, defined as follows: no need (or minimal need, meaning max. the 10% of the maximum dose) of vasopressore for 3 hours, with haemodynamic measurements, and arterial, central venous blood gas analysis, arterial lactate level measurement, venous and arterial pCO2-gap and O2 saturation measurements to confirm cardiorespiratory stability
次要结局
- Length of internsive care unit stay(From admission to intensive care unit until the end of intensive care unit assessed at study completion an avarage of 90 days)
- Change in interleukin-1 level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Interleukin-1ra level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Interleukin-8 level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Change in procalcitonine level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Change in interleukin-1ra level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Change in interleukin-8 level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Syndecan-1 level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Change in C-reactive protein level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Interleukin-1 level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Change in interleukin-10 level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Change in tumor necrosis factor alpha level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Procalcitonine level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Interleukin-6 level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Change in interleukin-6 level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- C-reactive protein level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Interleukin-10 level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Tumor necrosis factor alpha level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Change in arterial lactate levels level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Change in SOFA score(From the start of the treatment until the end of the treatment assessed up to 5 days)
- Change in extravascular lung water (EVLW)(From the start of the treatment until the end of the treatment assessed up to 5 days)
- Change in syndecan-1 level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Arterial lactate levels(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Adverse events(Recorded at the occurrance of adverse events, and study completion up to 90 +/- 7 days)
- Duration of mechanical ventilation(From the start of the treatment until the end of the treatment assessed up to 5 days)
- Heparan sulphate level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Change in heparan sulphate level(0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit)
- Duration of catecholamine requirement(From the start of the catecholamine requirement until the end of the catecholamine requirement assessed up to 5 days)
- Duration of renal replacement therapy(From the start of the renal replacement therapy requirement until the end of the renal replacement therapy requirement assessed up to 90+/-7 days at the second follow-up visit)
- Need for dialysis(day 28±7, day 90±7)
- Length of hospital stay(From admission to the hospital until the end of hospital stay assessed at study completion an avarage of 90 days)
- Survival(Rate if surviving patients assessed at death, or study completion which ever happens first, up to 90 +/-7 days)
研究者
研究点 (2)
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